Military Medical Research Ethics

2021 ◽  
Author(s):  
Michael L. Gross
Keyword(s):  
Informed Consent ◽  
Medical Research ◽  
Medical Devices ◽  
Military Medicine ◽  
Controlled Clinical Trials ◽  
High Quality ◽  
Emerging Therapies ◽  
Investigational Drugs ◽  
Medical Research Ethics ◽  
The Military

Military medicine presents unique challenges for medical research. Landing in Iraq, Coalition forces required investigational drugs to combat the threat of poison gas. As the fighting progressed, battlefield conditions necessitated rapid innovation to control bleeding, manage fluid resuscitation and transfusion, conduct field surgery, treat traumatic brain injury, develop limb prosthetics, and enhance performance. While clinicians delivered high-quality retrospective and survey studies, conditions unique to the military made it difficult to obtain informed consent and conduct controlled clinical trials of emerging therapies and medical devices. The result was a dearth of sufficient studies. Remedying the situation requires reformulating the rules of informed consent for military medical research and enlisting civilian subjects while protecting the rights and privileges of each group.

Military Medical Research and Experimentation

2021 ◽  
pp. 159-180
Author(s):  
Michael L. Gross
Keyword(s):  
Informed Consent ◽  
Medical Research ◽  
Gold Standard ◽  
Military Medicine ◽  
Experimental Studies ◽  
Research Subject ◽  
Research Subjects ◽  
Undue Influence ◽  
Effective Drugs ◽  
Modern War

Medicine is often unprepared for the physical and psychological wounds of modern war. Military medicine requires urgent research to treat traumatic brain injury, develop resuscitation techniques, upgrade surgical procedures, and acquire effective drugs. Retrospective, observational, and survey studies dominate the literature. However, clinically controlled experimental studies, the gold standard of medical research, are rare in military medicine. Stringent informed consent requirements to protect service members from coercion and undue influence make it difficult to enlist them for in-theater clinical studies. When a research subject is unconscious and his representative is unavailable to give consent, investigators can request waivers. But due to concerns about patient vulnerability, waivers are rarely granted to allow researchers to recruit injured soldiers in the field. Easing informed consent requirements to match those of civilian medical research, and intensifying efforts to recruit civilian research subjects during war will improve the prospects of clinical research.

Medical Research Ethics: What We Need to Comply When Obtaining Informed Consent from Human Subjects?

2009 ◽  
Vol 16 (4) ◽  
pp. 271-276
Author(s):  
CSK Tay
Keyword(s):  
Patient Safety ◽  
Informed Consent ◽  
Medical Ethics ◽  
Clinical Research ◽  
Medical Research ◽  
Research Ethics ◽  
Human Subjects ◽  
Well Being ◽  
Research Subjects ◽  
Medical Research Ethics

Patient safety and well-being are very important to safeguard in medical research. A subject's life cannot be sacrificed for the benefits of future mankind, as medical ethics of autonomy dictate the respect of an individual. By reference to the Declaration of Helsinki, this article discusses the ethical principles and processes in obtaining a valid and proper informed consent from the research subjects who should freely consent and voluntarily participate in the clinical research, including the ‘contents’ of the informed consent and the ‘skills’ of obtaining informed consent.

Military medical research in Britain and the USA: the challenge of informed consent

2018 ◽  
Vol 165 (4) ◽  
pp. 298-302
Author(s):  
Michael L Gross
Keyword(s):  
Informed Consent ◽  
Medical Research ◽  
Animal Studies ◽  
Public Discourse ◽  
Military Medicine ◽  
Experimental Studies ◽  
Research Subjects ◽  
Retrospective Case ◽  
Trauma Research ◽  
Combat Casualty

Military medical research requires informed consent from test subjects, which is difficult to obtain for deployed (in-theatre) or prehospital studies where patients are incapacitated and legal representatives are not available. Although US and UK regulations make provisions for exceptions to informed consent, these are rarely used, thereby hindering trauma research and prospective experimental studies of new devices, surgeries or drugs. In their place, a survey of research articles published in the Journal of the Royal Army Medical Corps and Military Medicine between 2004 and 2018 shows how researchers turned to clinical surveys and retrospective, case or animal studies instead. The reluctance to enrol military personnel in interventional studies stems from past instances of abuse and current misperceptions of soldiers as a particularly vulnerable class of research subjects. Increasing the pool of research subjects to facilitate interventional studies to improve combat casualty care requires honing military medical ethics in two ways. First, it is important to implement existing informed consent regulations without special regard for the status of service personnel. This will expedite approval of waivers of informed consent. Second, aggressively recruiting civilians for military-related medical research increases the number of subjects available for trauma research. Community consultation and public discourse are the proper venues to deliberate on each recommendation.

scholarly journals Von der Geomorphologie des Aargau zu den militärischen Pathologien Europas. Das Militär als Schnittpunkt anthropologischer Krisendiskurse, 1860–1900

Gesnerus ◽  
2015 ◽  
Vol 72 (2) ◽  
pp. 269-288
Author(s):  
Heinrich Hartmann
Keyword(s):  
Medical Research ◽  
19Th Century ◽  
Endemic Goiter ◽  
Military Medicine ◽  
Institutional Setting ◽  
Military Recruiting ◽  
Medical Discourses ◽  
The 19Th Century ◽  
The Military ◽  
Geological Research

Military statistics and medical research were closely related over the 19th century. The army not only made use of these new forms of knowledge, but also provided an important institutional setting through the military medicine, which was of crucial importance to medical research in the 19th century. Besides that, Swiss military also played a crucial role in new geographical and geological research, resulting in a series of new mapping projects. This article looks on the ways, in which military context gained influence on scientific research practices in the second half of the 19th century, by analyzing the case of Heinrich Bircher’s work on military recruiting statistics and the endemic goiter. New mapping projects and statistical practices were linked, transforming big parts of the country into pathological spaces. Coming from this point, the article discusses in how far the military context lead to politicizing medical discourses and, furthermore, linked them to discourses of an anthropological crisis, common in many European countries.

Tools and Resources: Web Sites of Interest

2001 ◽  
Vol 6 (2) ◽  
pp. 6-8
Author(s):  
Christopher R. Brigham
Keyword(s):  
Informed Consent ◽  
Physical Examination ◽  
Functional Status ◽  
Web Sites ◽  
Satisfaction Survey ◽  
High Quality ◽  
Diagnostic Studies ◽  
Physician Relationship ◽  
Complete History

Abstract The AMA Guides to the Evaluation of Permanent Impairment (AMA Guides), Fifth Edition, explains that independent medical evaluations (IMEs) are not the same as impairment evaluations, and the evaluation must be designed to provide the data to answer the questions asked by the requesting client. This article continues discussions from the September/October issue of The Guides Newsletter and examines what occurs after the examinee arrives in the physician's office. First are orientation and obtaining informed consent, and the examinee must understand that there is no patient–physician relationship and the physician will not provide treatment bur rather will send a report to the client who requested the IME. Many physicians ask the examinee to complete a questionnaire and a series of pain inventories before the interview. Typical elements of a complete history are shown in a table. An equally detailed physical examination follows a meticulous history, and standardized forms for reporting these findings are useful. Pain and functional status inventories may supplement the evaluation, and the examining physician examines radiographic and diagnostic studies. The physician informs the interviewee when the evaluation is complete and, without discussing the findings, asks the examinee to complete a satisfaction survey and reviews the latter to identify and rectify any issues before the examinee leaves. A future article will discuss high-quality IME reports.

scholarly journals In silico imaging clinical trials: cheaper, faster, better, safer, and more scalable

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Aldo Badano
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Medical Devices ◽  
In Silico ◽  
Lessons Learned ◽  
Patient Access ◽  
High Quality ◽  
Virtual Imaging ◽  
Regulatory Evaluation

AbstractImaging clinical trials can be burdensome and often delay patient access to novel, high-quality medical devices. Tools for in silico imaging trials have significantly improved in sophistication and availability. Here, I describe some of the principal advantages of in silico imaging trials and enumerate five lessons learned during the design and execution of the first all-in silico virtual imaging clinical trial for regulatory evaluation (the VICTRE study).

scholarly journals Developing a policy to reduce the salt content of food consumed outside the home in Malaysia: protocol of a qualitative study

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e044628
Author(s):  
Mhairi Karen Brown ◽  
Suzana Shahar ◽  
Yee Xing You ◽  
Viola Michael ◽  
Hazreen Abdul Majid ◽  
...  
Keyword(s):  
Medical Research ◽  
Research Ethics ◽  
Salt Intake ◽  
Salt Content ◽  
Ethics Committee ◽  
Salt Reduction ◽  
Reduction Strategy ◽  
Research Ethics Committee ◽  
School Canteen ◽  
Medical Research Ethics

IntroductionCurrent salt intake in Malaysia is high. The existing national salt reduction policy has faced slow progress and does not yet include measures to address the out of home sector. Dishes consumed in the out of home sector are a known leading contributor to daily salt intake. This study aims to develop a salt reduction strategy, tailored to the out of home sector in Malaysia.Methods and analysisThis study is a qualitative analysis of stakeholder views towards salt reduction. Participants will be recruited from five zones of Malaysia (Western, Northern, Eastern and Southern regions and East Malaysia), including policy-makers, non-governmental organisations, food industries, school canteen operators, street food vendors and consumers, to participate in focus group discussions or in-depth interviews. Interviews will be transcribed and analysed using thematic analysis. Barriers will be identified and used to develop a tailored salt reduction strategy.Ethics and disseminationEthical approval has been obtained from the Universiti Kebangsaan Malaysia Medical Research Ethics Committee (UKM PPI/1118/JEP-2020–524), the Malaysian National Medical Research Ethics Committee (NMRR-20-1387-55481 (IIR)) and Queen Mary University of London Research Ethics Committee (QMERC2020/37) . Results will be presented orally and in report form and made available to the relevant ministries for example, Ministry of Health, Ministry of Education and Ministry of Trade to encourage adoption of strategy as policy. The findings of this study will be disseminated through conference presentations, peer-reviewed publications and webinars.

Informed Consent in the Military: Fighting a Losing Battle Against the Anthrax Vaccine

2002 ◽  
Vol 28 (2-3) ◽  
pp. 325-343
Author(s):  
Ruth K. Miller
Keyword(s):  
Informed Consent ◽  
Service Member ◽  
Individual Choice ◽  
Civilian Life ◽  
Medical Treatments ◽  
Employment History ◽  
Receive Treatment ◽  
The Right ◽  
The Military ◽  
To Receive

In civilian life, an individual has the right to refuse medical treatment in almost any circumstance. While a patient who refuses treatment may face adverse consequences such as prolonged illness, our society recognizes the importance of individual choice in health matters. Members of the military, however, enjoy no such right. Service members are required to submit to certain medical treatments as a part of their employment contract. Refusing such treatments is disobeying an order, and the service member then faces the prospect of a dishonorable or “other than honorable” discharge, and even imprisonment. Disobeying an order to receive treatment can thus result in the equivalent of a felony conviction on the individual's employment history forever.

Therapeutic Discourse Among Nurses and Physicians in Controlled Clinical Trials

2008 ◽  
Vol 15 (6) ◽  
pp. 803-812 ◽  
Author(s):  
Susan L Instone ◽  
Mary-Rose Mueller ◽  
Tari L Gilbert
Keyword(s):  
Informed Consent ◽  
Term Treatment ◽  
Investigational Drug ◽  
Extensive Literature ◽  
Drug Trials ◽  
Treatment Trial ◽  
Controlled Clinical Trials ◽  
Professional Characteristics ◽  
Nurses And Physicians ◽  
Seriously Ill

An ethnographic field study about the informed consent process in investigational drug trials for seriously ill persons with hepatitis C suggests that nurses and physicians referred to these trials as giving treatment, even though they involved placebos. Interview data and informed consent documents contained frequent references to the term `treatment trial' or `treatment'. Although these findings were unexpected and not the original focus of our study, we consider them in the light of an extensive literature on the `therapeutic misconception' that has been described among physicians and patients with AIDS and other serious illnesses. We also suggest that certain organizational and professional characteristics of nursing and medicine reinforce this tendency to refer to the trials as treatment. Implications for further research are provided.

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